Plunger covers and plungers for use in syringes

ABSTRACT

A plunger cover for use with a syringe includes a sealing portion adapted to form a seal with the syringe and a central portion adapted to contact fluid within the syringe. The central portion can, for example, be more rigid than the sealing portion. The sealing portion and the central portion are connected in an overmolding process. The sealing portion can, for example, be formed from a thermoplastic elastomer or a thermoplastic polyurethane. The central portion can, for example, be formed from polypropylene, acrylonitrile butadiene styrene, polycarbonate or copolymers thereof.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.15/851,860, filed Dec. 22, 2017, which is a Continuation of U.S.application Ser. No. 14/576,354, filed Dec. 19, 2014, now U.S. Pat. No.9,855,390, which is a Division of U.S. application Ser. No. 11/686,000,filed Mar. 14, 2007, now U.S. Pat. No. 8,926,569, which claims benefitfrom the earlier filed U.S. Provisional Application Ser. No. 60/782,623,filed on Mar. 15, 2006, entitled “Plunger covers and plungers for use insyringes and methods of fabricating plunger covers and plungers for usein syringes,” and is hereby incorporated into this application byreference as if fully set forth herein.

BACKGROUND OF THE INVENTION

The present invention relates generally to plunger covers and toplungers for use in syringes and to methods of fabrication of plungercovers and plungers for use in syringes, and particularly, to plungercovers and to plungers for use in syringes to inject fluids into apatient and to methods of fabrication thereof.

A number of injector-actuated syringes and powered injectors for use inmedical procedures such as angiography, computed tomography, ultrasoundand magnetic resonance imaging (MRI) have been developed. U.S. Pat. No.4,006,736, the disclosure of which is incorporated herein by reference,for example, discloses an injector and syringe for injecting fluid intothe vascular system of a human being or an animal. Typically, suchinjectors comprise drive members such as pistons that operativelyconnect to a syringe plunger. For example, U.S. Pat. No. 4,677,980, thedisclosure of which is incorporated herein by reference, discloses anangiographic injector and syringe wherein the drive member of theinjector can be connected to, or disconnected from, the syringe plungerat any point along the travel path of the plunger via a releasablemechanism. A front-loading syringe and injector system is also disclosedin U.S. Pat. No. 5,383,858, the disclosure of which is incorporatedherein by reference. Front-loading syringes and syringe plungers for usetherewith are also disclosed in U.S. Pat. Nos. 6,585,700 and 6,224,577,the disclosures of which are incorporated herein by reference.

Forward, sliding motion of the syringe plunger within the syringe barrelpressurizes the fluid within the syringe, and the pressurized fluid isinjected into that patient via a syringe outlet. A common method ofmanufacturing syringe plungers adapted, for example, for use inconnection with powered injectors is to place an elastomeric, sealingplunger cover over a rigid base. Such rubber covers can, for example, bemanufactured by a vulcanization compression molding process. The rubbercovers can, for example, be molded into a sheet and then manually handcut (through a cutting die) from the sheet. Once cut, the rubber coversare, for example, washed in a silicone wash and then assembled onto aplunger base for insertion into a syringe. The process results insubstantial material waste and can also result in substantialmanufacturing costs and time.

U.S. Pat. No. 5,902,276, the disclosure of which in incorporated hereinby reference, discloses a syringe plunger that is formed by a two-shotmolding process. A hard plastic core is first formed in a first mold.Subsequently, the distal portion of the hard plastic core is overmoldedwith a soft rubber plunger cover in a second mold. The secondovermolding can occur in the second mold while the core is still coolingto effect molecular bonding of the rubber of the cover with the as-yetuncured plastic of the core.

WO 2004/035289, the disclosure of which is incorporated herein byreference, a copy of which is included herewith and made a part hereof,discloses a method of manufacturing plungers for medical syringeswherein the plunger includes at least two parts. In that regard, theplunger includes a plunger body made of a first plastic and a pistonbody (in the form of a sealing cover) at the front of the plunger bodymade of a second plastic. The second plastic (an elastomer) is softerthan the first plastic (a generally rigid plastic) of the plunger cover.In forming the plunger, the piston body is first formed by injectionmolding. Then, the plunger body (or a part thereof) is injected moldedagainst or over the piston body.

Although a number of syringe plungers and methods of fabrication ormanufacture of syringe plungers have been developed, it is desirable todevelop improved syringe plungers and methods of fabrication of syringeplungers.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a plunger cover for usewith a syringe including a sealing portion adapted to form a seal withthe syringe and a central portion adapted to contact fluid within thesyringe. The central portion can, for example, be more rigid than thesealing portion. The sealing portion and the central portion areconnected in an overmolding process. The sealing portion can, forexample, be formed from a thermoplastic elastomer or a thermoplasticpolyurethane. The central portion can, for example, be formed frompolypropylene, acrylonitrile butadiene styrene, polycarbonate orcopolymers thereof.

In several embodiments, the sealing portion is injection molded firstand the central portion is injection overmolded thereon. In otherembodiments, the central portion is injection molded first and thesealing portion is injection overmolded thereon. In several preferredembodiments, the sealing portion is injection molded first and thecentral portion is injection overmolded thereon. The material for thesealing portion and the material for the central portion can be selectedso that molecular bonding occurs between the sealing portion and thecentral portion.

In another aspect, the present provides a plunger for use with a syringeincluding a plunger cover including a sealing portion adapted to form aseal with the syringe and a central portion adapted to contact fluidwithin the syringe as described above. The central portion can, forexample, be more rigid than the sealing portion. The sealing portion andthe central portion are connected in an overmolding process. The plungerfurther includes a support attached to the plunger cover.

The sealing portion can, for example, includes a radially inwardprojecting flange that is seated within a seating formed on the supportto connect the plunger cover to the support. The support can, forexample, include a forward surface adapted to abut the plunger cover toprevent rearward motion of the central portion relative to the support.

In another aspect, the present invention provides a syringe including asyringe body and a plunger slidably positioned within the syringe body.As described above, the plunger includes a plunger cover including asealing portion adapted to form a seal with the syringe and a centralportion adapted to contact fluid within the syringe. The central portioncan, for example, be more rigid than the sealing portion. The sealingportion and the central portion are connected in an overmolding process.The plunger further includes a support attached to the plunger cover.

In a further aspect, the present invention provides a method offabricating a plunger cover for use in a syringe, including: connectinga sealing portion adapted to form a seal with the syringe and a centralportion adapted to contact fluid within the syringe in an overmoldingprocess, the central portion being more rigid than the sealing portion.The sealing portion can, for example, be injection molded first and thecentral portion is injection overmolded thereon. Alternatively, thecentral portion can be injection molded first and the sealing portion isinjection overmolded thereon.

In another aspect, the present invention provides a plunger cover foruse with a syringe including a sealing portion adapted to form a sealwith the syringe and a central portion adapted to contact fluid withinthe syringe. The central portion has at least one physiochemicalproperty that differs from the sealing portion. The sealing portion andthe central portion are connected in an overmolding process.

In another aspect, the present invention provides a plunger cover foruse with a syringe including a sealing portion adapted to form a sealwith the syringe and a central portion. The central portion is morerigid than the sealing portion. The sealing portion and the centralportion being connected in an overmolding process. In one embodiment,the central portion is positioned forward of at least a portion of thesealing portion and is adapted to contact fluid within the syringe. Inanother embodiment, the central portion is positioned rearward of agenerally central section of the sealing portion and does not contactfluid within the syringe. The central portion can, for example, beovermolded upon the sealing portion. Alternatively, the central portioncan be injection molded first and the sealing portion is injectionovermolded thereon.

In still a further aspect, the present invention provides a plunger foruse with a syringe including a sealing portion adapted to form a sealwith the syringe and a central portion adapted to contact fluid withinthe syringe. The central portion is, for example, more rigid than thesealing portion. The sealing portion and the central portion areconnected in an overmolding process. The sealing portion can, forexample, be adapted to form an operative connection with a drive member.

The present invention, along with the attributes and attendantadvantages thereof, will best be appreciated and understood in view ofthe following detailed description taken in conjunction with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A illustrates a perspective view of an embodiment of a plunger ofthe present invention.

FIG. 1B illustrates a perspective cutaway view of the plunger of FIG.1A.

FIG. 1C illustrates an enlarged cutaway view of a portion of the plungerof FIG. 1A.

FIG. 1D illustrates a rear perspective, exploded view of the plunger ofFIG. 1A wherein the plunger cover is disconnected from the base.

FIG. 1E illustrates a front perspective, exploded view of the plunger ofFIG. 1A wherein the plunger cover is disconnected from the base.

FIG. 1F illustrates a side schematic view of the plunger of FIG. 1Aslidably positioned within a syringe that is removably attached to apowered injector.

FIG. 2A illustrates a perspective view of another embodiment of aplunger of the present invention.

FIG. 2B illustrates a perspective cutaway view of the plunger of FIG.2A.

FIG. 2C illustrates an enlarged perspective cutaway view of a portion ofthe plunger of FIG. 2A.

FIG. 2D illustrates a rear perspective, exploded view of the plunger ofFIG. 2A wherein the plunger cover is disconnected from the base.

FIG. 2E illustrates a front perspective, exploded view of the plunger ofFIG. 2A wherein the plunger cover is disconnected from the base.

FIG. 3A illustrates a perspective view of another embodiment of aplunger of the present invention.

FIG. 3B illustrates a perspective cutaway view of the plunger of FIG.3A.

FIG. 3C illustrates a front perspective, exploded view of the plunger ofFIG. 3A wherein the plunger cover is disconnected from the base and thesealing portion of the plunger cover is separated from the central orcone portion of the plunger cover.

FIG. 3D illustrates a rear perspective, exploded view of the plunger ofFIG. 3A wherein the plunger cover is disconnected from the base and thesealing portion of the plunger cover is separated from the central orcone portion of the plunger cover.

FIG. 3E illustrates a front perspective view of the sealing portion ofthe plunger cover of FIG. 3A.

FIG. 3F illustrates a front perspective view of the central or coneportion of the plunger of FIG. 3A.

FIG. 4A illustrates a perspective view of another embodiment of aplunger of the present invention.

FIG. 4B illustrates a perspective cutaway view of the plunger of FIG.4A.

FIG. 4C illustrates a front perspective, exploded view of the plunger ofFIG. 4A wherein the plunger cover is disconnected from the base and thesealing portion of the plunger cover is separated from the central orcone portion of the plunger cover.

FIG. 4D illustrates a rear perspective view of the plunger cover of theplunger FIG. 4A.

FIG. 4E illustrates a front, cutaway perspective view of the plungercover of the plunger of FIG. 4A.

FIG. 4F illustrates a rear perspective, exploded view of the plungercover of the plunger of FIG. 4A wherein the sealing portion of theplunger cover is separated from the central or cone portion of theplunger cover.

FIG. 4G illustrates a front perspective, exploded view of the plungercover of the plunger of FIG. 4A wherein the sealing portion of theplunger cover is separated from the central or cone portion of theplunger cover.

FIG. 5A illustrates a front perspective view of another embodiment of aplunger of the present invention.

FIG. 5B illustrates a perspective, cutaway view of the plunger of FIG.5A.

FIG. 5C illustrates a rear perspective view of the plunger of FIG. 5A.

FIG. 5D illustrates a front perspective, exploded view of the plunger ofFIG. 5A.

FIG. 5E illustrates a front perspective, exploded view of the plunger ofFIG. 5A.

DETAILED DESCRIPTION OF THE INVENTION

One embodiment of a plunger 10 of the present invention is illustratedin FIGS. 1A through 1F. As illustrated, for example, in FIGS. 1D and 1E,plunger 10 includes a plunger cover 20 that contacts the fluid within asyringe 100 (see FIG. 1F) and forms a seal with the inner wall of thegenerally cylindrical barrel of syringe 100. Syringe 100 is adapted tobe removably connected to an injector 200 via, for example, a retainingflange 110 on syringe 100 the cooperates with a retainer on a syringeinterface 210 of injector 200. Injector 200 includes a drive member orpiston 220 moveable in a reciprocal manner to pressurize fluid withinsyringe 100.

Plunger cover 20 includes a sealing section 30 formed, for example, froman elastomeric material suitable to form a sealing engagement with theinner wall of syringe 100. Plunger cover 20 further includes a generallycentral portion 40 formed from a generally rigid polymeric material. Inthe embodiment of FIGS. 1A through 1G, central portion 40 has a conicalshape adapted to contact the injection fluid and to mate generally witha conical transition region 120 of syringe 100. Plunger 10 furtherincludes a base, support or support ring 50 to which plunger cover 20 isattached. In that regard, elastomeric sealing portion 30 includes aradially inward projecting flange 32 that is seatable within a seating52 formed in base 50. Base 50 further includes a forward surface 54 thatis shaped to contact and mate generally with a rearward surface ofplunger cover 20 and to provide support for plunger cover 20. In thatregard, abutment of forward surface 54 with plunger cover 20 limits orprevents rearward motion of plunger cover 20 relative to base or support50. To limit such rearward motion, forward surface 54 preferablycontacts a portion of plunger cover 20 so that at least a portion ofrigid central conical portion is in alignment with at least a portionforward surface 54. A rearward surface 56 of base 50 is adapted to becontacted by piston 220.

Preferably, plunger cover 20 is formed in an overmolding process such asdisclosed in WO 2004/035289. In an injection overmolding process, aninjection molding machine is used which includes a heated screw andbarrel that melt polymer to a liquid state. In general, an injectionmolding machine pushes/injects the molten polymer through a heatedmanifold system into a mold. Once the polymer is inside the mold, it iscooled to a final shape (as determined by the internal dimensions of themold), and then ejected. In general, waste material associated withinjection molding overmolding processes is less than associated withmany other manufacturing processes for multi-component articles.Moreover, the overmolding process can be operated automatically. Oncethe part is formed and cooled, no additional operations are required.

In one embodiment of an overmolding process of the present invention,sealing portion 30 of plunger cover 20 is first injection molded in anappropriately shaped mold. Examples of materials suitable for use ininjection molding sealing portion 30 include thermoplastic elastomers(TPE) or thermoplastic polyurethanes (TPU). In general, a thermoplasticelastomer or thermoplastic rubber (TPR) is a polymer compound or blendwhich exhibits a thermoplastic character above its melt temperature thatenables it to be shaped into a fabricated article. Within the designtemperature range, the material exhibits elastomeric behavior. In oneembodiment, sealing portion 30 was fabricated from SANTOPRENE®, a TPEavailable, for example, from Advanced Elastomer Systems, L.P. of Akron,Ohio. After injection molding of sealing portion 30, central portion 40of plunger cover 20 was molded over the TPE/TPU material of moldedsealing portion 30. Central portion 40 was injection overmolded with arigid polymeric material (for example, polypropylene, acrylonitrilebutadiene styrene (ABS) or polycarbonate (PC)). Copolymers such as, forexample, a PC/ABS copolymer are also suitable for use herein. Theovermolding process, for example, can be done in a manual transferredoperation or automatically within the same molding machine. In an insertmolding process, for example, sealing portion 30 is molded first.Sealing portion 30 is then inserted into another process/mold and isovermolded over with another polymer.

The overmolded polymer does not have to be rigid polymer. The overmoldedpolymer can, for example, be another polymer having differentphysiochemical properties. A multilayered plunger/plunger cover canthereby be formed. For example, a less expensive material can be used onan inner portion of the plunger/plunger cover and a more expensivematerial (having better functionality—for example, a medical gradematerial) can be used on the outside of the plunger/plunger cover.

As known in the overmolding arts, a molecular bond can be formed betweenthe material of sealing portion 30 and central portion 40. In additionto overmolding central portion 40 upon sealing portion 30, sealingportion 30 can be overmolded upon central portion 40. Control of thestrength of the molecular bond can be achieved by appropriate selectionof materials. In that regard, as known in the injection molding arts, toform a stronger molecular bond, the melt temperature of the firstinjected material is preferably similar to the melt temperature of thesecond, overmolded material. Materials that have dissimilar melttemperatures typically result in a weak molecular bond.

In addition to molecular bonding, sealing portion 30 and central portion40 can be shaped to interconnect mechanically to add structuralintegrity to the connection therebetween. For example, elastomericsealing portion 30 can be formed with a seating or groove 34 into whichan extending portion 42 of central conical section 40 (see, for example,FIG. 1C) extends during the overmolding process to provide mechanicalinterconnection and structural integrity to the connection betweensealing portion 30 and central portion 40.

As described above, elastomeric sealing portion 30 mates and form asealing engagement with the syringe barrel wall to seal fluid insidesyringe 100. As compared to plunger covers formed generally entirely ofan elastomeric material via, for example, a compression molding process,central conical portion 40, formed from a relatively rigid polymericmaterial, provides additional structural integrity. The increasedstructural integrity also reduces compliance. Overmolded plunger cover20 is a separate component of the plunger and can be assembled invarious configurations (for example, with different bases or supports orwithout a base or support). The design and manufacturing methodsassociated with plunger 10 reduce manufacturing costs, while maintainingfunctionality. The manufacturing process provides the capability ofcustomization of plunger cover 20. For example, colorants can be appliedto the rigid polymer cone for various purposes. Moreover, the overallshape of the plunger cover can readily be altered for use with differentsyringes. For example, the forward portion of the plunger cover can havea conical, hemispherical, flat or other shape to mate with acorrespondingly shaped syringe. In general, plunger 10 can replacecurrently available compression molded plunger covers in currentlyavailable plunger designs while maintaining or improving functionalityof those plunger designs.

FIGS. 2A through 2E illustrate another embodiment of a plunger 310 ofthe present invention which is similar in design, operation andmanufacture to plunger 10. In plunger 310, base or support 50 isidentical to that used in plunger 10. Plunger cover 320 differs fromplunger cover 20, for example, in the form of the mechanicalinterconnection between sealing portion 330 and central portion 340,which in the embodiment of FIGS. 2A through 2E is generally conical inshape. In that regard, For example, elastomeric sealing portion 330 isformed with a seating or groove 334 that is somewhat shorter in lengththan seating 34 of sealing portion 30. Similar to central portion 40,central portion 340 includes an extending portion 342 which extends intoseating 334 during the overmolding process. In the embodiment of FIGS.2A through 2E, forward surface 54 of base 50 contacts a rearward surfaceof central conical portion 340 directly (without any section of sealingportion 330 therebetween).

FIGS. 3A through 3F illustrate another embodiment of a plunger 410 ofthe present invention. Similar to plungers 10 and 310, plunger 410includes a plunger cover 420, which includes a sealing section 430formed, for example, from an elastomeric material such as a TPE/TPUmaterial. Plunger cover 420 further includes a generally conical centralportion 440 formed from a generally rigid polymeric material, preferablyin an overmolding process. Plunger 410 further includes base or supportring 50 as described above to which plunger cover 420 is attached. Inthat regard, elastomeric sealing portion 430 includes a radially inwardprojecting flange 432 that is seatable within seating 52 formed in base50. As with other embodiments of the present invention, however, plungercover 420 is readily adjusted in shape and dimension to mate with adesired support.

Central portion 440 can include extending tabs 442 which can assist informing a secure interconnection between central portion 440 and sealingportion 430. In general, such mechanical interconnections are optionalin all overmolding embodiments of the present invention. In theembodiment of FIGS. 3A through 3F sealing portion 430 includes agenerally conical central section 436 appropriately dimensioned suchthat the forward surface of central section 436 of sealing portion 430mates with the rearward surface of rigid conical central portion 440.Central section 436 of sealing portion 430 can, for example, providegreater area for molecular bonding between central portion 440 andsealing portion 430 during the overmolding process. Central section 436of sealing portion 430 can also provide for more effective molding ofplunger cover 420 in that injection gates for sealing portion 430 andcentral portion 440 can have the same general location.

FIGS. 4A through 4G illustrate another embodiment of a plunger 510 ofthe present invention. Similar to plunger 410, plunger 510 includes aplunger cover 520, which includes a sealing portion 530 formed, forexample, from an elastomeric material such as a TPE/TPU material.Plunger cover 520 further includes a generally conical central portion540 formed from a generally rigid polymeric material, preferably in anovermolding process. Plunger 510 further includes base or support ring50 as described above to which plunger cover 520 is attached. In thatregard, elastomeric sealing portion 530 includes a radially inwardprojecting flange 532 that is seatable within seating 52 formed in base50. As with other embodiments of the present invention, however, plungercover 520 is readily adjusted in shape and dimension to mate with adesired support.

In the embodiment of FIGS. 4A through 4G central portion 540 ispositioned to the rear of a generally conical central section 536 ofsealing portion 430. In this embodiment, rigid central portion 540 doesnot contact the injection fluid, but still provides structural integrityto plunger cover 520.

FIGS. 5A through 5E illustrate another embodiment of a plunger 610 ofthe present invention. Unlike the plunger embodiments set forth above,plunger 610 does not include a plunger base or support as, for example,described in connection with base or support ring 50. In that regard, asealing portion 630 (formed or molded from and elastomeric material suchas a TPE/TPU material) includes a seating 638 (for example, a threadedseating) to form a connection (for example, a removable connection) witha drive member. A rigid central portion 640 can, for example, beconnected with sealing portion 630 in an overmolding process asdescribed above.

The foregoing description and accompanying drawings set forth thepreferred embodiments of the invention at the present time. Variousmodifications, additions and alternative designs will, of course, becomeapparent to those skilled in the art in light of the foregoing teachingswithout departing from the scope of the invention. The scope of theinvention is indicated by the following claims rather than by theforegoing description. All changes and variations that fall within themeaning and range of equivalency of the claims are to be embraced withintheir scope.

1.-17. (canceled)
 18. A plunger cover for use with a syringe, theplunger cover comprising: a sealing portion having an outer sealingsection and a central section; and a central portion, wherein thesealing portion is made from a first material and the central portion ismade from a second material different than the first material, the firstmaterial being less rigid than the second material, and wherein thesealing portion and the central portion are overmolded such that thecentral section of the sealing portion and the central portion arecoextensively connected to form a multilayer portion of the plungercover.
 19. The plunger cover of claim 18, wherein the first material isa thermoplastic elastomer or a thermoplastic polyurethane.
 20. Theplunger cover of claim 18, wherein the second material is polypropylene,acrylonitrile butadiene styrene, or polycarbonate.
 21. The plunger coverof claim 18, wherein the first material and the second material areselected so that molecular bonding occurs between the sealing portionand the central portion.
 22. The plunger cover of claim 18, wherein thesealing portion and the central portion are shaped to interconnectmechanically.
 23. The plunger cover of claim 18, wherein the plungercover contains colorant.
 24. The plunger cover of claim 18, wherein thesealing portion comprises an inwardly projecting flange configured forbeing seated in a seating formed in a support ring.
 25. The plungercover of claim 18, wherein the central portion contains colorant.
 26. Aplunger for use with a syringe, the plunger comprising: a rigid supportring; and a plunger cover connected to the rigid support ring, theplunger cover comprising: a sealing portion made from a first material;and a central portion made from a second material different from thefirst material, wherein the first material is less rigid than the secondmaterial, and wherein the sealing portion and the central portion areovermolded such that the sealing portion and the central portion arecoextensively connected to form a multilayer portion of the plungercover.
 27. The plunger of claim 26, wherein the first material is athermoplastic elastomer or a thermoplastic polyurethane.
 28. The plungerof claim 26, wherein the second material is polypropylene, acrylonitrilebutadiene styrene, or polycarbonate.
 29. The plunger of claim 26,wherein the first material and the second material are selected so thatmolecular bonding occurs between the sealing portion and the centralportion.
 30. The plunger of claim 26, wherein the sealing portion andthe central portion are shaped to interconnect mechanically.
 31. Theplunger of claim 26, wherein the plunger cover contains colorant. 32.The plunger of claim 26, wherein the sealing portion includes a radiallyinward projecting flange that is seated within a seating formed on thesupport ring to connect the plunger cover to the support ring.
 33. Theplunger of claim 26, wherein a forward surface of the support ring abutsthe plunger cover to prevent rearward motion of the central portion ofthe plunger cover relative to the support ring.
 34. The plunger of claim26, wherein the central portion contains colorant.
 35. A syringecomprising: a syringe body and a plunger slidably positioned within thesyringe body, the plunger comprising: a rigid support ring; and aplunger cover connected to the rigid support ring, the plunger covercomprising: a sealing portion made from a first material; and a centralportion made from a second material different from the first material,wherein the first material is less rigid than the second material, andwherein the sealing portion and the central portion are overmolded suchthat the sealing portion and the central portion are coextensivelyconnected to form a multilayer portion of the plunger cover.